Evaluation of SaCoVLM™ Video Laryngeal Mask for Airway Management in Military Medics

NCT ID: NCT07249983

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-01-31

Brief Summary

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A prospective, two-phase interventional study evaluating the performance, safety, and usability of the SaCoVLM™ video laryngeal mask airway for airway management by military medics with limited intubation experience. The study includes simulation-based training and clinical application in sedated patients undergoing elective surgery.

Detailed Description

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This prospective, two-phase study evaluates the use of the SaCoVLM™ video laryngeal mask airway by military medics with limited airway experience. Phase 1 involves simulated intubation on manikins to assess device placement, visualization quality, and intubation success. Phase 2 evaluates clinical performance in adult patients undergoing elective surgery under general anesthesia. Key outcomes include first-attempt success rates, insertion and intubation times, glottic visualization scores, and complication rates. The study aims to determine whether SaCoVLM™ can enable safe and effective airway management in resource-limited and prehospital military settings.

Conditions

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Airway Management Tracheal Intubation Anesthesia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Simulation and Clinical Phase

Simulation-based and clinical use of SaCoVLM™ for airway management and intubation.

Group Type EXPERIMENTAL

SaCoVLM™ Video Laryngeal Mask

Intervention Type DEVICE

Simulation-based and clinical use of SaCoVLM™ for airway management and intubation.

Interventions

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SaCoVLM™ Video Laryngeal Mask

Simulation-based and clinical use of SaCoVLM™ for airway management and intubation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Elective surgery
* ASA I-II
* need for airway management

Exclusion Criteria

* Pregnancy
* known airway abnormalities
* allergy to anesthetics
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role lead

Military University Hospital, Prague

OTHER

Sponsor Role collaborator

Responsible Party

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Michal Soták

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michal Sotak, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Military University Hospital, Prague

Locations

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Military University Hospital Prague

Prague, , Czechia

Site Status

Countries

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Czechia

Central Contacts

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Jan Palenik, M.D.

Role: CONTACT

+420973203254

Josef Klecatsky, M.D.

Role: CONTACT

+420973202999

Facility Contacts

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Michal Sotak, M.D., Ph.D.

Role: primary

+420774830710

References

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Mishra N, Bharadwaj A. Comparison of Fiberoptic-Guided Tracheal Intubation Through Intubating Laryngeal Mask Airway (ILMA) FastrachTM and Ambu(R) Aura-i: A Randomized Clinical Study. Cureus. 2020 Sep 1;12(9):e10178. doi: 10.7759/cureus.10178.

Reference Type BACKGROUND
PMID: 33029458 (View on PubMed)

Other Identifiers

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SAVER-2025

Identifier Type: -

Identifier Source: org_study_id

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